US chemical plant security legislation 

The US Department of Homeland Security (DHS) has released its final list of federal security regulations governing US chemical plants.  

The 2001 terrorist attacks in New York brought security measures under scrutiny, but with America on high alert many felt that chemical plants were a high risk terrorist target that were being overlooked. More than five years on, these regulations have given the DHS the power to impose civil penalties and to close down plants that do not comply with minimum safety requirements.  

The department says it has developed the rules using a ’risk based’ approach. Owners of chemical facilities housing certain quantities of specified chemicals will be required to carry out a risk assessment on their facility. Any facilities that are deemed high risk will then have to submit a vulnerability assessment and site security plan. The DHS will validate submissions through audits and site inspections.  

This is the first time that a federal agency has been authorised to enforce security standards in the US chemical industry. It was greeted with rapturous praise by the American Chemistry Council (ACC), which responded with a statement saying ’the nation is safer today.’ 

But some believe that the rules do not go far enough and that defined federal rules pre-empt any individual states’ efforts to tighten their own security further. Frank Lautenberg, senator for New Jersey, called the regulations ’unacceptable’. ’This prevents New Jersey and other states from continuing to pursue stronger chemical security laws,’ he said. But the ACC are adamant that this marks progress. ’These new regulations will complement existing state programs and the significant security enhancements already undertaken voluntarily by our members to protect the chemical industry and the nation,’ it said.  

Peter Newport, director of the UK’s Chemical Business Association, told Chemistry World  that what he called America’s relatively more ’prescriptive’ legislation could cause problems, but that it was impossible to please everyone with the same guidelines. Drawing parallels between individual European countries and US states, he said, ’there is a different perception of the security threats in each country, so we need some flexibility in the legislation.’  

BASF and Monsanto collaborate 

German chemical company BASF and US biotech firm Monsanto have announced a $1.5 billion (£758 million) long-term joint R&D and commercialisation collaboration in plant biotechnology. They will focus on high-yielding and stress-tolerant crops. Project costs will be shared 50-50. Any products will be commercialised by Monsanto, which will receive 60 per cent of net profits. BASF put unfavourable results for its agriculture sector in 2006 down to ’unfavourable climatic conditions in important growing regions.’ 

AstraZeneca in China 

AstraZeneca has named Shanghai’s Zhanjiang Hi-Tech Park as a base for its Innovation Center China (ICC), which will focus on R&D on cancer drugs for the Chinese market. The facility, which is expected to support about 70 researchers, is scheduled to open in mid-2007. The company currently employs 2900 staff in China. 

Cancer vaccine licensing agreement 

UK biotech firm Oxford BioMedica has licensed its leading cancer drug, TroVax, to France’s Sanofi-Aventis. Oxford BioMedica will receive an initial payment of €29 million (£19.7 million) and further near-term payments of €19 million as milestones linked to an ongoing Phase III trial of the cancer vaccine in renal cancer. The upfront payment will give the loss-making company funds to develop other experimental treatments in its pipeline. Oxford BioMedica is reported to be focusing on its neurotherapy pipeline - particularly on its gene therapy for Parkinson’s disease, ProSavin, which is expected to enter clinical development this year. 

Parkinson’s drug pulled 

The US Food and Drug Administration (FDA) has announced that manufacturers of pergolide, a drug for Parkinson’s disease - marketed as Permax by US drug company Eli Lilly - will voluntarily remove these drugs from the market because of the risk of serious damage to patients’ heart valves. Pergolide is a member of a class of drugs known as dopamine agonists and is used with levodopa and carbidopa to manage the signs and symptoms (tremors and slowness of movement) of the disease. The decision follows two studies published in January this year in The New England Journal of Medicine

All eyes on new blockbuster 

US biotech firm Genentech enjoyed a 61 per cent jump in first-quarter profits accompanying news that its drug Lucentis, a treatment for serious eye disease, is approaching blockbuster drug status. Drugs become blockbusters when yearly sales reach $1 billion. Sales of Lucentis, which stems bleeding in small blood vessels in the eye - the cause of age related macular degeneration - hit $211 million in US sales in the first quarter. 

Dow’s secret sale saga 

Rumours of a takeover by private equity buyers, that were vehemently denied by Dow Chemical, have now led to the dismissal of two executives, accused of secretly planning the sale.  

Director Pedro Reinhard and Romeo Kreinberg, executive vice-president of performance businesses, were fired for allegedly engaging in ’highly inappropriate’ business activity.  

Both men strenuously refuted claims that they conspired with banks and foreign governments to sell the company, and have now hired attorneys to investigate their legal options. 

GSK opens Singapore lab 

Pharma giant GlaxoSmithKline (GSK) has opened a medicinal chemistry laboratory on Singapore’s Biopolis science park (see Chemistry World, January 2006). The new lab, which will employ 27 chemists working alongside GSK’s existing biologists, more than doubles the area the company takes up at Biopolis. By integrating its biology labs with its medicinal chemistry lab, GSK aims to have one target ready for clinical trials by the end of the year. 

Oxonica’s woes 

Leading UK nanotech firm Oxonica has suffered major challenges to its prime revenue driver, the fuel additive Envirox.  

The Guardian  reported at the end of March that share prices had slumped 16.5p to 117.5p following reports of inconclusive results from an Envirox trial in Turkey. Envirox is designed to increase diesel fuel efficiency. The results put at risk a £6.1 million deal that the company signed with Turkish oil and gas company Ofisi in 2006.  

This news was followed by a report in The Times  that Oxonica has filed a patents suit in the High Court in London, following claims by a small private research company, Neuftec, that Oxonica is using its technology illegally. Oxonica licensed a core patent underpinning the fuel catalyst technology from Neuftec and developed a method to improve its dispersion and settling properties in diesel fuel. The Neuftec license was expected to run until the patent expires on 29 June 2021, according to Oxonica. The license is based on a combination of royalty and milestone payments and profit share.  

Environmental cooperation 

The US and India have renewed a memorandum of understanding to work cooperatively on environmental issues. The MOU focuses on four priorities: air quality; water quality; toxic chemicals and waste; and the management of environmental agencies. The renewed commitment builds on earlier work. The US Environmental Protection Agency (EPA) is working with the Hyderabad Metropolitan Water Supply and Sewerage Board and the World Health Organization to prevent drinking water contamination. 

Abbott agrees access to HIV drug 

Abbott Laboratories has agreed to expand access to its blockbuster HIV therapy Kaletra. Over 40 low income countries and NGOs will be offered the drug at the reduced price of $1,000 (£500) per patient per year, undercutting the cost of generic versions. The deal was initiated by the World Health Organization. Abbott said that its aim was to ’increase affordability while preserving the system that enables the discovery of new medicines’. This follows the decision by Thailand’s health minister, earlier this year, to break Abbott’s patent and grant a compulsory licence for the production of a generic version of Kaletra. 

Cholesterol controversy 

Trial results for pharmaceutical giant AstraZeneca’s cholesterol-lowering drug Crestor (rosuvastatin) have been met with both applause and suspicion, depending where you look. The company itself reported that results of its Meteor (Measuring effects on intima media thickness: an evaluation of rosuvastatin) trial were the first to show a positive effect on atherosclerosis in people with early signs of carotid artery disease and at low risk of coronary heart disease.  

However, AstraZeneca’s share price saw a fall of 1.3 per cent following the announcement, coupled with the observation that the drug did not reduce existing plaque build up in the same patient group.  

Cholesterol reduction is big business: Pfizer’s drug Lipitor is the world’s most prescribed branded drug, with annual sales of $13 billion. 

H5N1 vaccine 

The FDA has approved the first US vaccine for avian influenza virus H5N1. The success of the vaccine, produced by Sanofi-Aventis group’s vaccine business, Sanofi Pasteur, followed the results of a clinical trial conducted by the National Institute of Allergy and Infectious Diseases. Sanofi Pasteur will not commercialise the vaccine; it has been bought by the federal government for inclusion in the US Strategic National Stockpile, for distribution by public health officials if needed.  

The vaccine will be produced at Sanofi Pasteur’s Swiftwater facility in Philadelphia.